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Register:	ISRCTN
Last refreshed on:	5 August 2022
Main ID:	ISRCTN23201971
Date of registration:	26/03/2014
Prospective Registration:	Yes
Primary sponsor:	Institut de Recherches Internationales Servier (France)
Public title:	Phase Ib dose allocation study of oral administration of lucitanib given in combination with fulvestrant in patients with metastatic breast cancer
Scientific title:	Phase Ib dose allocation study of oral administration of lucitanib given in combination with fulvestrant in patients with oestrogen receptor-positive and FGFR1-amplified or non-amplified metastatic breast cancer
Date of first enrolment:	04/04/2014
Target sample size:	46
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN23201971
Study type:	Interventional
Study design:	Multicentric open non-comparative phase Ib study (Treatment)
Phase:	Phase I

Countries of recruitment
France

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Mario Campone
Address:	Institut de Cancérologie de l'Ouest René Gauducheau Département de Cancérologie Boulevard Jacques Monod 44805 Saint-Herblain France
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: 1. Menopausal women aged 18 years old or over
2. Histologically confirmed breast adenocarcinoma
3. Relapsing during or after treatment with fulvestrant
4. Tumour progression at study entry demonstrated by radiological assessment
5. Adequate haematological, hepatic and renal functions
Exclusion criteria: 1. Previously treated with more than three chemotherapy regimen in the metastatic/advanced setting
2. Previous treatment with bevacizumab within 3 months before the first day of lucitanib administration
3. Active central nervous system metastases, cerebral oedema, and/or progressive growth
4. Patients with impaired cardiac function
5. Serum potassium level below lower limit of normal
6. Uncontrolled hypothyroidism
7. Pregnant or breastfeeding women
8. Patient with any other concomitant severe and/or uncontrolled medical condition that would, in the investigators' opinion, contraindicate patient participation in the clinical study

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

FGFR1-amplified or non-amplified estrogen receptor positive metastatic breast cancer
Cancer
Malignant neoplasm of breast

Intervention(s)

1. Capsules containing 5, 10 or 15 mg of lucitanib taken orally on a daily basis, treatment duration at the investigator's discretion
2. Concomitant intramuscular injection of fulvestrant 500 mg on a monthly basis

The study is composed of two successive parts: the dose allocation (Continual Reassessment Method) and the dose expansion part.

For the dose allocation cohorts, a minimum of three patients will be enrolled at the initial dose level of 10 mg once per day in combination with fulvestrant. Patients will be included by groups of three. A minimum of nine patients will be included at the Maximal Tolerated Dose. Intra-patient dose-escalation will be considered in the patient's best interest.

For the dose expansion part, two cohorts of 14 patients will be treated with the lucitanib Recommended Dose defined in the dose allocation part of this study in combination with fulvestrant given on a monthly basis.

In both parts, each patient will receive the combination of lucitanib with fulvestrant until unacceptable toxicity according to the investigator, disease progression or patient withdrawal. The maximum number of cycles is at the discretion of the investigator.

Primary Outcome(s)

1. Maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of lucitanib in combination with fulvestrant, at the end of dose allocation cycles
2. Safety profile of lucitanib in combination with fulvestrant at each visit

Secondary Outcome(s)

1. Clinical benefit rate (CBR), progression-free survival (PFS) and duration of response over the study
2. Pharmacokinetic and pharmacodynamic profile of lucitanib in combination with fulvestrant at each cycle

Secondary ID(s)

CL1-80881-002

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethics approval was obtained before recruitment of the first participants

Results

Results available:	Yes
Date Posted:
Date Completed:	06/03/2017
URL:

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